Licensing

As of November 2020, at least 44 manufacturing and production deals for COVID-19 therapeutics around the globe were made public. A number of these deals were intended to expand access to therapeutics to low and middle-income countries. In relation to all of them, licensing, enabled by a well well-functioning intellectual property system, has been a key enabler.

• Eli Lilly and Company and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19, to benefit low- and middle-income countries. Lilly’s collaborators have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative.
• Gilead has entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process.
• Merck, IAVI, and Serum Institute of India are collaborating to develop a neutralizing monoclonal antibody treatment for COVID-19. If successful, Merck will lead commercialization in developed countries and the Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.

The need for the rapid development and global distribution of a vaccine to prevent COVID-19 infection has spurred a number of novel collaborations between the pharmaceutical companies, research entities, and other stakeholders. These collaborations aim to ensure broad access to new health technologies to address the pandemic.

• One example is the University of Oxford Jenner Institute vaccine candidate, developed with AstraZeneca, that included collaborations with Catalent Biologics (Italy), Symbiosis Pharmaceutical Services (UK), Oxford Biomedica (UK), Emergent BioSolutions, BioKangtai (China), and R-Pharm (Russia). Through the WHO’s Access to COVID-19 Tools Accelerator, AstraZeneca signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance, on vaccine development, manufacturing, and procurement, ensuring 300 million doses of the vaccine for low- and middle-income countries. Separately, AstraZeneca also signed a license agreement with the Serum Institute of India (SII) to supply 1 billion doses of vaccine to low- and middle-income countries.
• Another example involves Sanofi and GSK, which signed a Statement of Intent with Gavi, to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities.
• A third example focuses on Johnson & Johnson.  The company has committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021.

This September 2020 LeadershIP webinar features senior officials from the United States DOJ, PTO, and NIST discussing intellectual property protection and enforcement, and the relevance of competition rules to IP licensing, in the wireless technology sector.  Among other topics, the speakers discuss the challenge of patent hold-out, whereby standard essential patent (SEP) owners face unwilling licensees engaged in ongoing infringement of their IPRs, and confirm their shared view that injunctive relief should be available without restrictions for SEPs.